During early phase clinical trials, strategic and timely collection of data is integral to the development process and for guiding critical decision-making. Our renowned expertise at INC Research ensures robust study design, clinical conduct, and informative data interpretation to guide your clinical development planning.
Specialized sites in locations that make research easier
Phase I clinical development outside of the United States is a growing strategic choice to enable more enriched pre-IND discussions. We have Early Phase units in Canada and Australia. Both locations are customized to early phase research in diverse study populations.
In Canada, there is no requirement for pre-Clinical Trial Applications (CTAs), and your CTA won’t need study reports. CTAs are reviewed within 30 days (with a target timeline of seven days for some phase I studies), and the IMPD is simple to prepare.
Australia likewise offers a simple and speedy regulatory process, where the onus falls primarily on the ethics committee, often granting CTA approval in as little as four weeks from submission. Additionally, you can perform your first-in-human study before opening an IND, and take advantage of both the seasonal differences and the Australian Government’s pro-research program (currently rewarding up to 43.5% refunds in tax).
Our research practices are ICH-compliant, yielding globally acceptable data with minimal reporting requirements. Our studies have been routinely reviewed by leading regulatory agencies globally.
Coming to Canada or Australia can yield currency exchange advantages, and we can help you benefit from government tax credits along the way.
Our early phase experience is wide-ranging
We’ve conducted multiple early phase studies in the following areas. Simply contact us if you’d like further details about our experience in a specific field.
- Abuse potential/liability
- Alcohol interaction
- Biologics and new chemical entities
- CNS disorders
- Controlled substances
- Dose proportionality
- Drug-drug interaction
- Food effect
- Methadone interaction
- Patient bridging
- Pharmacodynamic models
- Super protocols (combining multiple cohorts to answer several questions in one study)
- Transdermal systems
- Intranasal and other routes of administration
We’re global leaders in abuse potential assessment of CNS-active drugs with vast experience conducting specialized and NDA-enabling early phase studies
Abuse potential evaluation is an integral assessment in the development of both NCEs that are CNS active and formulations with abuse deterrent features.
Our Early Phase unit in Canada is a center for excellence in abuse potential evaluation. We will assist in developing your abuse potential evaluation process and in conducting human abuse potential studies. For NCEs, such evaluations are essential in understanding the safety profile of your compound, and help to guide scheduling decisions. For abuse deterrent formulations, abuse potential evaluation is the cornerstone for your proof of concept and in supporting important labelling information.
Having worked with many challenging drug development programs, we have extensive experience to help guide you.
We can grant access to a diverse volunteer database
Located in the heart of downtown Toronto, the fourth largest city in North America, our site in Canada provides you with an extensive database of Early Phase volunteers and the largest database of recreational drug users (for abuse potential studies), in a place that is easily accessible by public transport. Our volunteers can readily participate in both confined and out-patient studies.
Our study database contains over 27,000 volunteers, differentiated by all sorts of conditions. These include ADHD, asthma, Parkinson’s/movement disorders, Alzheimer’s disease, clinical depression, hypertension, migraine, type II diabetes, and also alcohol users (high, moderate, low), non-dependent recreational drug users (sedatives, stimulants, opiates), stable methadone users, poor and extensive metabolizers, smokers and non-smokers, post-menopausal women, elderly, and ethnic groups.
Take a look at our study volunteer website: studies4u.com
We’re equipped to generate the data you need
Your studies will be overseen by our full time, on-site physicians, ACLS-certified research nurses and paramedics, research technicians and security staff, as well as benefitting from our examination and procedure suites, separate monitor supervision rooms, outpatient assessment and screening facilities.
Our state-of-the-art facility in Canada is designed for CNS trials with an emphasis on ensuring subject safety while maintaining comfort. In both Canada and Australia, we’ve got the right equipment to enable continuous cardiac telemetry monitoring, ECG, EEG, cognitive battery testing (21 CFR part 11 compliant), and imaging (including PET and fMRI). We have fully-equipped crash carts and an emergency generator. Additionally, we have in-house laboratories for sample preparation, handling and storage, and in-house pharmacists experienced with investigational medicine import and handling.
We like to work with very different medicines
We get excited when your research ambitions intend to break the boundaries of modern medicine. To accomplish this, you’ll often need to develop a new research or data capture technique. We’ve advanced our early phase resources by our commitment to research and development in advancing clinical trial methodologies. Our team is actively involved in monitoring and contributing to the evolving regulatory requirements for Early Phase studies. We are committed to provide you with current and best practices.
Our proprietary electronic capture system (PsychometRx™) is 21 CFR part 11 compliant and contains a wide array of validated pharmacodynamics assessments enabling characterization of your investigational product. This system has generated extensive data for hundreds of early phase studies for successful submission and review by regulatory authorities.